Influenza Vaccine in Lung Transplant Patients
Research Question: How do antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation and healthy individuals?
Experimental Design: This interventional parallel group study will compare influenza vaccine induced immune responses in three groups: lung transplant patients, individuals waiting for lung transplantation and healthy individuals.
Current and Future Research Activities: Blood will be drawn for these measures of vaccine induced antibody response before and 2 to 4 weeks after immunization. Another blood draw will be obtained from up to 30 individuals from among the three groups for measures of T cell response to immunization. The third blood draw will be done during months 1 to 5 following influenza immunization. Genetic material (DNA) will be obtained from cells in the blood to look for genetic markers that may be associated with influenza vaccine response. Blood draws and immunization for the healthy participants will be done at the General Clinical Research Center (GCRC) or in the Clinical Research Facility in Rennebohm Hall. The blood draws for the pre-transplant and post-transplant patients will be coordinated with clinically indicated laboratory tests in order to avoid additional venipunctures. Influenza immunization is part of the routine clinical care of patients with lung disease, and only the immune response data will be considered part of the research study.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Influenza Vaccine in Lung Transplant Patients|
- Antibody response to influenza vaccine [ Time Frame: Each season ] [ Designated as safety issue: No ]
- T cell response to influenza vaccine antigens [ Time Frame: Each season for the first two seasons ] [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Drug: Influenza vaccine
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205270
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Mary S Hayney, PharmD||University of Wisconsin, Madison|